Abstract
DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR DETERMINATION OF MERCAPTOPURINE-AN ANTI CANCER DRUG IN PHARMACEUTICAL FORMULATIONS

Pallapati Suman, Tirukkovalluri Siva Rao*,  Dr. S. Radha Krishna, Kallam Venkata Siva Rama Krishna Reddy

ABSTRACT

A quantitative determination of Mercaptopurine in pharmaceutical formulation employing a very simple and rapid chromatographically technique was validated and developed. The analysis was performed at temperature (25 ± 2 °C) by employing a reverse phase Kromasil C18 (250mm x 4.6mm, 5μm) column and a mobile phase made up of methyl alcohol, acetonitrile, and water in the ratio of 50:15:35 (v/v/v) at rate of flow of 0.9 mL/min and analyte was detected at 217nm by employing a UV-detector. During this method, Mercaptopurine has separated altogether the formulations within 6.1min. The Linear calibration curves obtained the concentration range of 2-12μg/mL and the correlation coefficient is 0.9993 for Mercaptopurine. Stress testing was accomplished to reveal the specificity of the optimized chromatographic HPLC method. This proposed method was suitable for the separation Mercaptopurine and its degradative products in pharmaceutical formulations.

Keywords: Mercaptopurine, RP-HPLC, Stability-indicating method, Method Validation, ICH, MERCAPTO©.


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